On June 6, 2022 National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, reported it has raised $625 million in a Series D financing, in addition to a previously unannounced $600 million Series C financing completed in August 2021 (Press release, National Resilience, JUN 6, 2022, View Source [SID1234615653]).

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The company will use the funding to continue to invest in building its infrastructure network through strategic collaborations, acquisitions, organic growth and international expansion, and by developing innovative biomanufacturing technologies to ensure the medicines of today and tomorrow can be made quickly, safely and at scale. Resilience is also investing in advanced R&D, including stable cell lines for viral vector production, distributed manufacturing for autologous cell therapy and cell-free and continuous manufacturing for biologics.

"We have an ambitious goal to reinvent biomanufacturing by bringing new processes and technologies to an industry that hasn’t kept pace with the explosive innovation in drug discovery," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "While we recognize that our goal is neither quick nor easy, we are driven by our mission to democratize access to medicines. These new funds will help support our next phase of growth, as we continue to innovate biomanufacturing across all our modalities, expand our footprint to serve customers, sign strategic collaborations and support the developers of a new generation of complex medicines."

Resilience, which focuses on five therapeutic modalities – biologics, vaccines, nucleic acids and cell and gene therapies – currently has 10 facilities across North America, with more than 1 million square feet of manufacturing space and more than 1,600 employees. The company’s network, which is expected to add capacity and capabilities this year with projects underway at several existing sites, is agile enough to scale customer projects from process and analytical development through preclinical to large scale commercial drug substance and drug product manufacturing.

Resilience‘s flexible business model enables it to partner with customers of any size and across therapeutic modalities, through fee-for-service arrangements, value-share agreements and new company creation/incubation projects. The company also provides opportunities for early access and out licensing of next-generation technologies. Beyond industry customers and partners, Resilience works with government agencies, academic institutions and non-profit organizations.

The latest up-round financing was led by new and existing investors, including venture capital funds, public mutual funds, pension funds, biopharma companies, sovereign wealth funds and private family offices, among others. In total, Resilience has secured more than $2 billion in equity financing since its founding in 2020.

Recent Notable Milestones and Developments

Technology:

Acquired SwiftScale Biologics, a company developing cell-free protein synthesis, a technology that aims to eliminate the constraints of using living cells in the drug manufacturing process, resulting in faster production times, less variability across batches and greater scalability with hard-to-produce proteins.
Customers:

Established a multi-product development and manufacturing collaboration with Takeda’s Plasma-Derived Therapies Business Unit.
Secured a contract with the U.S. Department of Defense for manufacturing a monoclonal antibody as a medical countermeasure to botulinum neurotoxins.
Signed a strategic manufacturing services agreement with Opus Genetics, a gene therapy company developing treatments for inherited retinal diseases.
Manufacturing Infrastructure:

Acquired bluebird bio’s Research Triangle manufacturing facility in North Carolina.
Added capacity and capabilities including drug substance and drug product manufacturing expansions coming online in 2022 across sites in Alachua, FL, Boston and Toronto, to support biologics and vaccines.
Constructing a new, state-of-the-art facility in Marlborough, MA to support vaccines and gene therapy, coming online in 2023.
Adding a new cell and gene therapy process and analytical development as well as drug substance manufacturing site in the Philadelphia region.
Academic Collaborations & Incubations:

Launched a joint venture with The University of Texas MD Anderson Cancer Center to accelerate the development and manufacturing of innovative cell therapies for patients with cancer.
Entered into a five-year R&D alliance with Harvard University to incubate new technologies and launch companies to advance the manufacture of complex medicines.
Formed a strategic collaboration with Children’s Hospital of Philadelphia (CHOP) to implement next-generation biomanufacturing technologies and capabilities aimed at accelerating the creation of impactful therapies and technologies for the benefit of patients.
Value-Share Agreements:

Formed a strategic collaboration with Be Biopharma to manufacture engineered B Cells to create a new class of autologous and allogeneic cellular medicines.

On June 6, 2022 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported results from the myCare-004 study, which demonstrate that the Cellworks Singula Therapy Response Index (TRI) is highly predictive of Overall Survival (OS), Disease-Free Survival (DFS) and Mandard-tumor regression grade (TRG) for gastroesophageal adenocarcinoma (GEA) patients (Press release, Cellworks, JUN 6, 2022, View Source [SID1234615652]). In this retrospective study, Singula TRI provided additional predictive information for OS and DFS beyond patient age, patient gender and physician-prescribed treatment.

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The results from the myCare-004 clinical study were featured in a poster session as part of the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting during the Gastrointestinal Cancer – Gastroesophageal Pancreatic and Hepatobiliary Track and available online as Abstract 4064.

"This study confirmed that there are many dysregulated signaling pathways responsible for hallmark behaviors of cancer and variable drug response in gastroesophageal adenocarcinoma patients," said Dr. Elizabeth Smyth, Cambridge University Hospitals NHS Foundation Trust and Co-Principal Investigator of the myCare-004 clinical study. "Cellworks personalized therapy biosimulation enables us to utilize a patient’s comprehensive next generation sequencing (NGS) results and understand the downstream molecular effects of specific drugs on cell signaling to predict how each patient will respond to therapies prior to treatment. The next step is to evaluate whether biosimulation-informed therapy selection can be used prospectively to improve the survival of GEA patients."

"Gaining a better understanding of the molecular determinants of gastroesophageal adenocarcinoma is key to improving therapy response rates for GEA patients," said Dr. Rebecca Fitzgerald, MD, Professor of Cancer Prevention at the University of Cambridge; Director of the CRUK Cambridge Centre Early Detection Institute; and Co-Principal Investigator of the myCare-004 clinical study. "There are limited treatment options for this cancer type and we look forward to testing the Cellworks personalized therapy predictions in a prospective trial."

The Cellworks Biosimulation Platform simulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Omics Biology Model (CBM), a network of 7,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. As part of the biosimulation process, personalized disease models are created for each patient using their cytogenetic and molecular data as input to the Cellworks CBM. The Cellworks platform analyzes the impact of specific therapies on the patient’s personalized disease model and generates a Singula biosimulation report with Therapy Response Index (TRI) scores from 0 to 100 that predict the efficacy of specific chemotherapies.

myCare-004 Clinical Study

Background

In this study, the Cellworks Singula Therapy Response Index (TRI) was used to prospectively predict the Overall Survival (OS), Disease Free Survival (DFS) and Mandard-tumor regression grade (TRG) in a retrospective cohort of gastroesophageal adenocarcinoma patients from the UK OCCAMS consortium. 271 GEA patients were selected who had pre-chemo treated biopsies with 50x whole genome sequencing. 234 patients were male and 30 female with a median age of 65.6 years. Within the study population, there were 35 T2, 215 T3, 70 N0, 126 N1, 62 N2 and 266 M0. Patients were prescribed chemotherapy treatments according to UK clinical guidelines.

Methods

A mechanistic model created for each patient using comprehensive genomic inputs biosimulated downstream molecular effects of cell signaling and drugs for a patient’s personalized in silico disease model. Random sampling stratified by clinical factors was used to split the data into independent training (N=140) and validation (N=131) subsets. Multivariant Cox Proportional Hazard (PH) and Proportional Odds models were used to predict survival and pathological response as a function of the pre-defined Therapy Response Index (TRI) and clinical thresholds compared with standard clinical factors.

Results

Cellworks Personalized Therapy Biosimulation found that 99% of the patients’ tumors had deficiency in DNA repair genes. Other pathways included amplification of multi-drug resistance pumps, TP53 mutations and aberrations of the PI3K/AKT pathway genes. Cellworks Singula Therapy Response Index (TRI) provided additional predictive information for OS and DFS beyond physician prescribed treatment and standard clinical factors. TRI was also predictive of TRG in univariate analysis. TRI scores were generated for 82 alternate therapies for each patient, enabling selection of optimal therapies with estimates of improvements in median OS and DFS compared to standard care (SC).

Conclusions

The study found that Cellworks Singula TRI was predictive of Overall Survival (OS), Disease-Free Survival (DFS) and Mandard-tumor regression grade (TRG) beyond clinical factors in this cohort of gastroesophageal adenocarcinoma (GEA) patients. These positive results suggest the utility of biosimulation-informed therapy selection to improve survival of GEA patients.

On June 6, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that Chief Executive Officer, Zachary Hornby, will present at the 2022 Jefferies Healthcare Conference, which will take place in New York City (Press release, Boundless Bio, JUN 6, 2022, View Source [SID1234615651]). Presentation details are as follows:

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Date: Thursday, June 9, 2022
Time: 10:30 AM ET
Location: New York Marriott Marquis

On June 6, 2022 TwinStrand Biosciences, Inc., the pioneer in duplex sequencing technology, reported that the company will present several data sets as part of its sponsorship and participation in the annual Advances in Genome Biology and Technology conference in Orlando on June 6-9, 2022 (Press release, TwinStrand Biosciences, JUN 6, 2022, View Source [SID1234615650]). The studies will highlight advances in TwinStrand’s innovative technology and share recent research that demonstrates the power of duplex sequencing for some of the most demanding applications in clinical and foundational research.

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"At TwinStrand, we continue to make progress and see the impact of our technology in important areas like hematology-oncology, genetic toxicology, and cellular therapies," said Jesse Salk, M.D., Ph.D., TwinStrand’s Cofounder, and CEO. "We are pleased to share this progress with the AGBT community and look forward to forming new collaborations that leverage our highly sensitive and specific Duplex Sequencing technology which has consistently demonstrated its potential as a critical decision support tool in medicine, public health, and other fields of science where high-resolution insights are most impactful."

TwinStrand DuplexSeq AML-29 Minimal Residual Disease (MRD) Assays offer high-sensitivity detection of ultra-low frequency mutations in acute myeloid leukemia (AML) cases. The 29-gene panel covers loci that are mutated in up to 95% of adult AML patients and is several orders of magnitude more sensitive and specific than other next-generation sequencing-based (NGS) MRD assays. TwinStrand is a member of the Foundation for the National Institutes of Health Biomarkers Consortium, which recently launched a program to validate and standardize methods of detecting and quantifying MRD in AML patients.

TwinStrand DuplexSeq Mutagenesis Assays offer a novel NGS-based approach to mutational research that detects, quantifies, and characterizes genome mutagenesis. It is the first NGS technology able to directly measure ultra-rare mutations caused by chemical carcinogens, without requiring biological selection and is applicable in vitro and in vivo. The final output is comprehensive data on induced mutations including frequency, simple spectrum, and trinucleotide signatures. TwinStrand is collaborating with the Health and Environmental Sciences Institute (HESI), the UK branch of the European Environmental Mutagenesis Society (UKEMS), and the US National Institutes of Standards (NIST) to showcase the value of error-corrected NGS for various preclinical research and regulatory applications.

AGBT attendees can learn more about TwinStrand technology in the Escambia suite. The company will share details from its pioneering work and partnerships in the field of genetic toxicology, which has significant implications for future regulatory mutagenicity and carcinogenicity testing. Other data sets will showcase recent applications of TwinStrand DuplexSeq products in acute myeloid leukemia and allogeneic cell therapy, including:

Ultra-Sensitive Duplex Sequencing for Quantifying Multi-Individual Cell Therapy Sub-Population Fractions
Authors from TwinStrand Biosciences and Deverra Therapeutics
Duplex Sequencing for Ultra-Low Frequency Measurable Residual Disease Detection in Adult Acute Myeloid Leukemia
Authors from TwinStrand Biosciences, Fred Hutchinson Cancer Research Center, National Heart, Lung, and Blood Institute – National Institutes of Health, and Children’s Hospital Los Angeles
Duplex Sequencing Reveals Ubiquitous Clonal Hematopoiesis and Complex Donor-Recipient Clonal Dynamics Following Hematopoietic Stem Cell Transplant
Authors from TwinStrand Biosciences and Fred Hutchinson Cancer Research Center
Longitudinal Monitoring of Pediatric Acute Myeloid Leukemia Using Duplex Sequencing of Patient-Specific Panels Reveals Ultra-Low Frequency MRD that Marks Persistent Carcinogenesis and Complex Clonal Evolution
Authors from TwinStrand Biosciences, Fred Hutchinson Cancer Research Center, and University of California San Francisco

On June 6, 2022 Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, is showcasing new instruments, workflows, software and industry collaborations that enable customers to generate new analytical insights and accelerate next generation vaccine and therapy development (Press release, Thermo Fisher Scientific, JUN 6, 2022, View Source [SID1234615649]). The company will showcase these innovations during the 70th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, being held June 5-9, 2022, in the Minneapolis Convention Center, Minneapolis.

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"Our newest innovations are focused on improving each of the critical steps in an end-to-end mass spectrometry workflow," said John Lesica, president, chromatography and mass spectrometry, Thermo Fisher Scientific. "New instruments, consumables, workflows and software solutions enable leading-edge biological research that spans the molecular spectrum—from targeted and small molecule quantitation and advancements in high-throughput quantitative proteomics and bio-molecular characterization to a revolution in intuitive, AI-driven software."

Enabling Next Generation Therapies

To improve material quantitation and accelerate biopharma development, Thermo Fisher has added a new Thermo Scientific Direct Mass Technology mode for its Thermo Scientific Q Exactive UHMR Hybrid Quadrupole-Orbitrap mass spectrometers that lets manufacturers analyze the characteristics of biotherapeutics in greater detail throughout development. For proteomics researchers, the Thermo Scientific AccelerOme Automated Sample Preparation Platform improves reproducibility in sample prep, a longstanding bottleneck preventing wider use in biomarker discovery for disease detection and research into new therapies.

A new Thermo Scientific µPAC Neo HPLC Column improves column-to-column reproducibility within proteomics and biopharmaceutical research applications as part of an end-to-end liquid chromatography-mass spectrometry (LC-MS) workflow. This further simplifies complex bottom-up proteomics analyses, enabling wider use in discovery and detection of cancer and other disease biomarkers and in development of new therapies and vaccines ranging from COVID to cancer and rare diseases.

Unlocking Deeper Analytical Insights

The new cloud-based Thermo Scientific Ardia platform integrates data across multiple chromatography and mass spectrometry instruments, letting biopharmaceutical and proteomics scientists share previously siloed data, simplifying analyses and unlocking deeper insights into new diagnostics and therapies that could reach the point of care sooner.

New Thermo Scientific BioPharma Finder 5.1 software uses advanced algorithms to improve biotherapeutic characterization, an increasing priority as industry and regulators build stricter quality controls into the production of complex new biotherapies and vaccines.

For proteomic scientists, Thermo Scientific Proteome Discoverer 3.0 software interprets data from Thermo Scientific Orbitrap mass spectrometers and applies artificial intelligence (AI), giving researchers a faster method to identify and analyze billions of possible protein interactions in humans, insights that accelerate discovery and development of next-generation drugs and vaccines.

Lastly, for forensic toxicologists, clinical research toxicologists, employee drug testing facilities and wellness organizations, expanding the Thermo Scientific Tox Explorer Collection onto the Thermo Scientific Orbitrap Exploris Mass Spectrometer platform, provides an all-in-one LC-MS toxicology solution to solve complex analytical challenges and increase laboratory productivity.

Cross Industry Collaboration

Thermo Fisher has entered a relationship with TransMIT GmbH Center for Mass Spectrometric Developments to promote a mass spectrometry imaging (MSI) platform for spatial multi-omics applications in pharmaceutical and clinical laboratories. The Thermo Scientific Orbitrap MS instrumentation, coupled with TransMIT’s AP-SMALDI5 AF Ion Source, enables higher-resolution spatial distribution mapping of cancer and other complex tissues to improve disease detection.